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MK0826, ertapenem

Phase 3

Colorectal Surgery | Small molecule | Gastrointestinal |Merck & Company, Inc.|Last Updated: Feb 20, 2017

Target and mechanism

ModalitySmall molecule

Also known as MK0826, ertapenem sodium, MK0826,Duration of Treatment: 8 Weeks

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment952

FDA Designations

No designations recorded

Clinical trial landscape

MK0826, ertapenem · 8 trials · 13 indications

Phase 3 6Phase 2 2
NCT00398099To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)Infection
COMPLETED30 Analytics
NCT00397956To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)Sepsis
COMPLETED30 Analytics
NCT00090272A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)Colorectal Surgery
COMPLETED952 Analytics
NCT00481702A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)Intra-abdominal Infection
COMPLETED300 Analytics
NCT00389987Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)Complicated Intra-Abdominal Infections
COMPLETED300 Analytics
NCT00229112Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)Foot Infections in Diabetic Patients
COMPLETED400 Analytics
PHASE3COMPLETED
To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)
InfectionUnlock trial analytics
PHASE3COMPLETED
To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
SepsisUnlock trial analytics
PHASE3COMPLETED
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)
Colorectal SurgeryUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Intra-abdominal InfectionUnlock trial analytics
PHASE3COMPLETED
Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
Complicated Intra-Abdominal InfectionsUnlock trial analytics
PHASE3COMPLETED
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)
Foot Infections in Diabetic PatientsUnlock trial analytics

Study Endpoints

Primary Endpoints

Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Surgical site infection following elective colorectal surgery based on surgical site assessment.
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
2 weeks after treatment
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
2-weeks post-treatment
Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy
To evaluate the incidence of any clinical and/or laboratory drug-related serious adverse experience during the parenteral therapy period in pediatric patients treated with ertapenem.

Secondary Endpoints

Safety and Tolerability
Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
4 weeks after treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
MK0826, ertapenem sodium / Duration of Treatment: 14 DaysDRUG -
MK0826, ertapenem sodiumDRUG -
Comparator: cefotetanDRUG -
Comparator: ceftriaxone sodium / Duration of Treatment: 8 WeeksDRUG -
MK0826, /Duration of Treatment : 8 WeeksDRUG -
Comparator: metronidazole / Duration of Treatment: 8 WeeksDRUG -
Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 WeeksDRUG -
MK0826, ertapenem sodium / Duration of Treatment - 24 weeksDRUG -
Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeksDRUG -
Comparator: Ticarcillin/ClavulanateDRUG -
MK0826, ertapenem sodium /Duration of Treatment: 14 DaysDRUG -
Comparator: ceftriaxone sodium /Duration of Treatment: 14 DaysDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female patients, 20 years of age or older * Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment * Patients who required thera...

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Frequently asked questions about MK0826, ertapenem

What is MK0826, ertapenem used for?

MK0826, ertapenem is an anti-infective agent studied for treating complicated intra-abdominal infections, colorectal surgery infections, foot infections in diabetic patients, and other bacterial infections. It has been evaluated in Phase 3 trials for these indications, including intra-abdominal infections and sepsis.

Who is developing MK0826, ertapenem?

MK0826, ertapenem is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical trials evaluating this anti-infective agent for various infection types.

What phase is MK0826, ertapenem in?

MK0826, ertapenem is in Phase 3 clinical development. It has completed at least one Phase 3 trial, and additional Phase 2 and Phase 3 trials have also been completed. It is an investigational agent and has not been approved by the FDA for the studied indications.

What clinical trials is MK0826, ertapenem in?

MK0826, ertapenem has been studied in completed trials including NCT00481702, a Phase 3 trial in intra-abdominal infections; NCT00451386, a Phase 2 trial in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia; NCT00398099, a Phase 3 trial in various infections; and NCT00397956, a Phase 3 trial in complicated infections including sepsis.

Is MK0826, ertapenem the same as ertapenem sodium?

Yes, MK0826, ertapenem is also known as ertapenem sodium. The names MK0826 and ertapenem refer to the same anti-infective agent developed by Merck. Variations such as MK0826, ertapenem sodium /Duration of Treatment: 14 Days and MK0826, ertapenem/Duration of Treatment: 14 Days are alternative designations for the same compound.